Catalog Number

-

Brand Name

TALOS®-C

Version/Model Number

530-205-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142345,K150788

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Public Device Record Key

62b1a417-2764-4a14-8732-f2b3692d8e6f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-